A Diagnostic Test on DeepDoc-an AI-based Decision Support System

December 11, 2019 updated by: Xijing Hospital

DeepDoc - Clinical Validation of an AI-based Decision Support System in the Early Diagnostic Evaluation of Neurological Diseases: a Prospective Multi-center Study

DeepDoc is an AI-based decision support system for the early etiology diagnosis of neurological diseases using clinical data points from patients admitted to hospital within 24 hours.This study aims to evaluate whether the diagnosis of the DeepDoc AI-based decision support system is better than the doctor's initial diagnosis by a multi-center, superiority diagnostic study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The doctor completes the admission note within 24 hours after the patient is admitted to the hospital. After informed consent is given to the patient who meet the inclusion criteria, open the DeepDoc to fill in the patient identification information. Then take the picture of the initial diagnosis of the admission note page and upload it to DeepDoc, fill the doctor's initial diagnosis into the DeppDoc. And put the patient's clinical data points into the DeepDoc to get a DeepdDoc diagnosis.

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

4000 consecutive patients suspected of stroke，meningitis/encephalitis, vertigo and headache（1000 cases of each disease) are admitted to the department of neurology that consented to involvement in the study.

Description

Inclusion Criteria:

  1. Patients with clinical symptoms or signs suspected of stroke，meningitis/encephalitis, vertigo and headache.
  2. Neurological examination results and imaging changes within 24 hours of admission.

Exclusion Criteria:

Patients discharged, transferred to the hospital, or died within 24 hours after admission.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Meningitis/Encephalitis
Patients with clinical signs and symptoms suspected of meningitis/encephalitis
Device: DeepDoc AI-based Decision Support System
Patients are diagnosed by the DeepDoc within 24 hours of admission.
Stroke
Patients with clinical signs and symptoms suspected of stroke
Device: DeepDoc AI-based Decision Support System
Patients are diagnosed by the DeepDoc within 24 hours of admission.
Headache
Patients with clinical signs and symptoms suspected of headache
Device: DeepDoc AI-based Decision Support System
Patients are diagnosed by the DeepDoc within 24 hours of admission.
Vertigo
Patients with clinical signs and symptoms suspected of vertigo
Device: DeepDoc AI-based Decision Support System
Patients are diagnosed by the DeepDoc within 24 hours of admission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of diagnosis by DeepDoc AI-based Decision Support System
Time Frame: 24 hours
Accuracy of diagnosis by DeepDoc and compare this result with doctors
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of diagnosis by DeepDoc AI-based Decision Support System
Time Frame: 24 hours
Sensitivity of diagnosis by DeepDoc and compare this result with doctors
24 hours
Specificity of diagnosis by DeepDoc AI-based Decision Support System
Time Frame: 24 hours
Specificity of diagnosis by DeepDoc and compare this result with doctors
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Director: Zhao Gang, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

September 9, 2020

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

August 4, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (ACTUAL)

August 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DeepDoc-M5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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